End Stage Renal Disease, Pruritus
Conditions
Keywords
End Stage Renal Disease, Cromolyn Sodium, Pruritus, Tryptase
Brief summary
Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.
Interventions
DRUGcromolyn sodium
oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks
DRUGplacebo
capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Hemodialysis patients \> 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs * Willing and able to give informed concent
Exclusion criteria
* Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus * Lactase deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pruritus | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| serum tryptase level | 4 months |
Countries
Iran
Outcome results
None listed